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- NCIT_C41335 IAO_0000115 "Any expected or unexpected adverse event, related or unrelated to the intervention, occurring at any agent dose, any phase of product or procedure testing, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect. Important medical events that may not result in the listed outcomes may be considered as serious when, based upon appropriate medical judgment, they represent significant hazards or potentially serious harm to the research subject or others and may require medical intervention to prevent one of the outcomes listed in this definition." @default.
- NCIT_C41335 NCIT_NHC0 "C41335" @default.
- NCIT_C41335 NCIT_P106 "Finding" @default.
- NCIT_C41335 NCIT_P108 "Serious Adverse Event" @default.
- NCIT_C41335 NCIT_P207 "C1519255" @default.
- NCIT_C41335 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C41335 NCIT_P325 "Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction." @default.
- NCIT_C41335 NCIT_P366 "Serious_Adverse_Event" @default.
- NCIT_C41335 normalizedInformationContent "100" @default.
- NCIT_C41335 referenceCount "1" @default.
- NCIT_C41335 hasExactSynonym "SAE" @default.
- NCIT_C41335 hasExactSynonym "Serious Adverse Event" @default.
- NCIT_C41335 hasExactSynonym "serious adverse event (SAE)" @default.
- NCIT_C41335 inSubset NCIT_C61410 @default.
- NCIT_C41335 inSubset NCIT_C67497 @default.
- NCIT_C41335 type Class @default.
- NCIT_C41335 isDefinedBy ncit.owl @default.
- NCIT_C41335 label "Serious Adverse Event" @default.
- NCIT_C41335 subClassOf NCIT_C3367 @default.
- NCIT_C41335 subClassOf NCIT_C36291 @default.
- NCIT_C41335 subClassOf NCIT_C41331 @default.
- NCIT_C41335 subClassOf NCIT_C41335 @default.
- NCIT_C41335 subClassOf NCIT_C52680 @default.
- NCIT_C41335 subClassOf NCIT_C7057 @default.